Clinical trial · Interventional
DEB-TACE Prior to Liver Transplantation in the Treatment of HCC
A Prospective, Single Arm, Exploratory Study of Using Drug-eluting Beads Transarterial Chemoembolization Prior to Liver Transplantation in the Treatment of Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to living donor liver transplantation can prolong the recurrence-free survival in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory study. The patients scheduled for living donor liver transplantation receive DEB-TACE 2 weeks prior to the surgery. The primary outcome: Recurrence-free survival (RFS) The secondary outcome:1) Overall survival (OS);2) Pathological response rate (Pathological Response); 3) Proportion of patients completing living donor liver transplantation; 4) Adverse events related to DEB-TACE.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEB-TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DEB-TACE prior to living donor liver transplantation
- description
- Patients with HCC scheduled for living donor liver transplantation treatment receive DEB-TACE 2 weeks prior to the surgery
- interventionNames
- Procedure: DEB-TACE
Primary outcomes (1)
- measure
- Recurrence-free survival (RFS)
- timeFrame
- 2 years
- description
- the time from DEB-TACE treatment until tumor recurrence in the original site, transplanted liver, other tissues and organs, or death, whichever occurs first.
Secondary outcomes (4)
- measure
- Overall survival (OS)
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years; 2. Subjects with viral hepatitis or cirrhosis are clinically diagnosed according to AASLD standards, which require a history of viral hepatitis or cirrhosis combined with imaging examinations (enhanced CT, MRI, second-generation ultrasound contrast agents). When the tumor diameter is greater than 2 cm, a diagnosis can be made if one imaging technique shows typical arterial phase rapid enhancement and rapid washout. If the diameter is 1-2 cm, two imaging techniques must confirm this, or one imaging technique confirms it and alpha-fetoprotein (AFP) is greater than 400 ng/ml. For subjects who cannot be clinically diagnosed, histological or cytological biopsy confirmation is required; original biopsy records can also be used for diagnosis. 3. Child-Pugh score A-B grade; 4. Tumor present in the right lobe of the liver; 5. Liver cancer assessment meeting the "up to seven" criteria: the sum of tumor size and number does not exceed 7; 6. ECOG-PS score 0-1; 7. Scheduled for living donor liver transplantation as the primary treatment; 8. Signed informed consent form. Exclusion Criteria: 1. Presence of definite cancer thrombi in the main portal vein, vena cava, or main bile duct; 2. Severe hepatic encephalopathy; 3. Coexisting pulmonary arterial hypertension (moderate to high risk, WHO Grade III-IV); 4. Severe contrast agent allergy; 5. Irreversible hepatic artery to hepatic vein shunt; 6. Special types of anatomical variations (Asan portal vein type III); 7. Extrahepatic metastatic tumors; 8. Concurrent active hepatitis or severe infection; 9. Tumor dissemination or distant metastasis, expected survival \<3 months; 10. Renal dysfunction, creatinine \>176.8 umol/L or creatinine clearance rate \<30ml/min; 11. White blood cell count \<3.0x109/L, platelet count \<50x106/L, and unable to correct; 12. Inability to tolerate surgical anesthesia (severe infection, cardiopulmonary insufficiency, cerebrovascular disease); 13. Severe psychiatric illness; 14. Other reasons deemed unsuitable for participation by the investigator.
References
Publications (0)
Data not yet available